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Case Still Open on Vytorin-Cancer Link

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Though it did not make much of a ripple when it was first released, a study that linked Vytorin to cancer might re-emerge to raise serious questions next week. That is because the full SEAS study is going to be released, and cardiologists and other experts can be expected to show much more skepticism towards Merck and Schering-Plough’s reassurances that its cancer findings were nothing more than an anomaly than the media has.

SEAS was designed to see if Vytorin provided any benefit to patients with a disorder called aortic stenosis. In the SEAS trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo. Those findings are considered statistically significant, meaning the odds were less than 5 percent that they were the result of chance.

According to Forbes.com, the way Merck and Schering-Plough released the preliminary SEAS data earlier enabled the drug makers to control the fallout. At a company-funded press conference on July 21 to release the data, the companies had Richard Peto, an Oxford University statistician present data from two much larger ongoing studies of Vytorin. Peto claimed that the additional studies showed that the cancer risk was a statistical fluke. He called the contention that Vytorin could cause cancer ‘bizarre’,” according to Forbes.

But several experts interviewed by Forbes said that there is just not enough information available to reach any conclusions about Vytorin’s cancer risks. The data “are not definitive at all,” says James Stein, a cardiologist at the University of Wisconsin, Madison. He told Forbes that Vytorin should remain “a third-line drug” until more data can be collected.

More than dozen top experts surveyed by Forbes about SEAS also expressed doubts about Peto’s analysis. Eight said that Peto was wrong to completely dismiss the possibility that Vytorin might be linked to cancer. Ten thought there was at least some chance that Vytorin increases the risk of death for patients who have cancer. Peto’s analysis did not even address that possibility.

Next week, when the entire SEAS study is vetted, it is likely that many more experts will voice similar concerns.

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